Closing the Treatment Gap: A Pilot Study of Evidence-based Guided Self-Help for the Treatment of Binge Eating and Related Disordered Eating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Ratings of Acceptability of intervention to participants
研究概览
简要总结
The purpose of the present pilot study is to evaluate the feasibility, acceptability and likely effectiveness of an evidence-based guided self-help intervention for binge eating and related disordered over-eating in those unable to access clinician provided treatments. If feasible, acceptable and likely to be effective, such interventions could be made available more widely as an early intervention to those in need. Such interventions have the potential to improve quality of life by removing or ameliorating symptoms that impair psychological and social functioning. Eligible participants will receive the guided self-help intervention - an evidence-based self help program in the form of a self-help book plus telephone support and encouragement to follow the program provided by specially trained help-line volunteers. Support completing the self-help program will be provided over a period of 4 months and participants will be followed up for a year after completion of the intervention. Participants will be asked to complete brief online assessments before starting the program, at the end of 4 months when they complete the program and at 6 month and 12 month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant contacted National Eating Disorder Association (NEDA) with binge eating problems or disordered overeating
- •Completed NEDA screen and study screen
- •Age 18 and over
- •Able to speak, understand and read English
- •Consenting to guided self-help and completing study assessments
排除标准
- •Currently receiving treatment for an eating disorder
- •Self-reported weight body mass index (BMI) <20
- •Reported self-induced vomiting, laxative or diuretic use (purging)
- •Reports suicidal ideation
- •Breast feeding or pregnant
- •Receiving treatment for co-existing psychiatric condition (e.g., bipolar disorder, psychotic illness, drug or alcohol dependence
研究组 & 干预措施
Self-help CBT
Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide
干预措施: Cognitive behavioral therapy guided self help (CBTgsh) (Behavioral)
结局指标
主要结局
Ratings of Acceptability of intervention to participants
时间窗: 16 months
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
时间窗: 16 weeks
Percentage of eligible participants who complete intervention
Feasibility of providing intervention-consent
时间窗: week 0 (baseline)
Percentage of eligible participants who consent to intervention
Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
时间窗: 16 weeks
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of participants' satisfaction with intervention
时间窗: 16 months
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
时间窗: At Baseline - before start of intervention
Participants' ratings of suitability of intervention on visual analogue scale with anchors of strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
时间窗: 16 weeks
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
时间窗: 10 months
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of participants' satisfaction with intervention
时间窗: 10 months
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
次要结局
- Likely effectiveness -Eating difficulties(week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention))
- Likely effectiveness - impairment due to eating difficulties(Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention))
- Likely effectiveness - depression(Week 0 and week 64 (48 weeks/1 Year after end of intervention))
- Likely effectiveness -Eating difficulties(week 0 (baseline) and week 16 (end of intervention))
- Likely effectiveness - impairment due to eating difficulties(Week 0 (baseline) and week 16 (end of intervention))
- Likely effectiveness - depression(Week 0 and week 16 (end of intervention))
研究者
Zafra Cooper
Professor of Psychiatry (adjunct)
Yale University